It would either be classified as a Class 1 or 2 medical device as its a non intrusive device used under the supervision of a caretaker. The FDA has a seperate arm which deals with Telehealth or ehealth companies exactly like ePat.
Every jurisdiction has a different standard but largely the FDA is seen as the gold standard. If ePat can concentrate their approval with the FDA then this will go a long way in gaining approval in Australia with the TGA and other countries.
ResApp conducted a pre submission meeting with the FDA who outlined clinical requirements before they end up submitting results for approval around mid this year. This is where ePat would receive specific feedback around their clinical data.
The submission process would approximately take 120-180 days.
ePat I believe would bring huge value to the developing world. World Health Organisation do not need FDA approval to start using products so this could also be a great avenue to start with. All you need is a nurse and a smartphone.
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